Facilities Qualification Specialist - GMP Validation Expert

Veg Group; Aguadilla (PR); On-site; USD 95,000 - 130,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a Facilities Qualification Specialist to lead room and facility qualification under GMP guidance.

You will verify architectural features, pressure relationships, and environmental conditions, and generate IQ/OQ protocols with supporting evidence for execution. The role involves documenting discrepancies, coordinating retesting, and delivering complete qualification packages including the Qualification Summary Report and traceability matrices.

Qualifications

• Bachelor's degree in Engineering or related field.
• Prior hands-on experience developing and executing qualification protocols or CSV lifecycle documents and tests.
• Experience supporting qualification or CSV work in pharmaceutical, biologics, or comparable GxP environments.
• Ability to interpret technical documents and write qualification or validation reports.

Responsibilities

• Lead qualification of rooms, architectural elements and supporting facility features within scope.
• Verify room IDs, boundaries, dimensions, finishes, penetrations and cleanable features against drawings.
• Verify access points, airlocks, doors, interlocks and room status within facility boundary.
• Review utility points, labels, fixtures, lighting and drainage for qualification readiness.
• Generate IQ/OQ protocols and support routing to execution, document discrepancies and deviations.
• Coordinate retesting after approved actions and assemble complete qualification packages.
• Maintain weekly forecast, deliverable tracker, and time records for assigned work.
• Produce Qualification Summary Report and Requirements Traceability Matrix.

Skills

English proficiency

GxP familiarity

Regulatory knowledge

Education

Bachelor's degree in Engineering or related field

Job description

Validation & Engineering Group, Inc. seeks a Facilities Qualification Specialist to lead room and facility qualification under GMP guidance.

You will verify architectural features, pressure relationships, and environmental conditions, and generate IQ/OQ protocols with supporting evidence for execution. The role involves documenting discrepancies, coordinating retesting, and delivering complete qualification packages including the Qualification Summary Report and traceability matrices.